Safety and efficacy of Levucell® SB ( Saccharomyces cerevisiae CNCM I-1079) as a feed additive for weaned piglets and sows

Levucell® SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. Saccharomyces cerevisiae is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to establish safety for the target species, consumers and the environment. The identity of the strain present in the additive was established. Accordingly, this strain is presumed safe for the target species, consumers of products from animals fed the additive and the environment. Based on the data provided, the formulation Levucell® SB20, the uncoated form, is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in two other forms (Levucell® ME10 and Levucell® ME Titan) is not expected to introduce hazards for users. In four studies conducted in sows, the supplementation of Levucell® SB in the sows’ feed at the recommended dose increased the daily weight gain of piglets. Consequently, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that Levucell® SB has the potential to be efficacious in sows at the dose of 1 x 109 colony-forming unit (CFU)/kg feed. The results in the studies done in weaned piglets showed that the supplementation of Levucell® SB in the feed at the recommended dose resulted in a statistically significant improvement on the feed to gain ratio in two studies and in an improvement of the final body weight (and average daily weight gain) in another study. The FEEDAP Panel concluded that Levucell® SB has the potential to be efficacious in weaned piglets at the dose of 2 x 109 CFU/kg feed.